Vagal Nerve Stimulation for Gastroparesis

NCT03120325 | Terminated Results FDA Device

• 1 other identifier: 39839
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

This study is investigating a new form of treatment for a digestive disorder called gastroparesis. Gastroparesis is thought to be caused by a mix of inflammation and neural dysfunction. The vagal nerve is a large nerve originating from the brain that regulates digestive function. Patients with gastroparesis have what is a called a low vagal tone which results in gastrointestinal motility problems and inflammation; therefore, investigators hypothesize that increasing vagal tone through a hand-held vagal nerve simulator will reduce inflammation and gastrointestinal motility problems in gastroparesis patients. Investigators will evaluate this hypothesis through the use of upper endoscopy testing, breath testing, and blood, stool, urine, heart rate variability, and saliva testing before and after 4 weeks of vagal nerve stimulation (VNS) treatment. There are 6 research visits Visit 1 and visit 2 may take up to 8 weeks (screening/baseline) Visit 3 and visit 4 will take 4 weeks (VNS treatment) visit 5 and 6 will take approximately 4 weeks (VNS followup/washout) Consequently, it is possible that if a patient were to be at the farthest ends of visit windows, they could potentially be in the study for approx 16 weeks. Visit 1 and 2 may be less than 8 weeks which would shorten the patient's overall involvement in the study. The treatment phase of the study will always be 4 weeks with an additional 4 week washout phase. Use of the VNS device takes 4 weeks. Endoscopy and blood work are taken before and after the treatment period.

Conditions

Gastroparesis

Outcome Measures

Primary Outcomes (2)

• Effect of Vagal Nerve Stimulation on Gastroparesis Symptoms as Measures by the Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD) Questionnaire.

  Investigators will send daily GCSI-DD to patients for 8 weeks. This 10 item questionnaire measures the severity of gastroparesis symptoms on a scale 0-5. 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, 5=very severe. Investigators hypothesize a change of more than 0.75 points. Scored were recorded daily at each time point and scores then averaged to produce an overall score (range: 0 to 5, higher scores correspond to worse symptoms).

  Baseline (2 weeks prior to initiation), week 4 (7 days), week 8 (7 days)

• Effect of Vagal Nerve Stimulation on the Gastric Emptying Spirulina Breath Test Emptying Time

  Investigators will measure a change in gastric emptying time before and after vagal nerve stimulation as measured in minutes. Higher number (longer times) indicate more severe gastroparesis.

  Baseline and week 4 (3 hours to assess at each time point)

Secondary Outcomes (6)

• PROMIS Pain Interference Questionnaire Score as a Measure of the Effect of VNS Therapy on Overall Pain

  Baseline, week 4, week 8

• Short Form 12 (SF-12) Score the Effect of VNS Therapy on Overall Wellbeing and Health

  Baseline, week 4, week 8

• Number of Participants With Any Serious or Treatment-emergent Adverse Event (AE) as a Measure of the Safety and Tolerability of VNS in Patients With Gastroparesis

  8 weeks

• Heart Rate Variability (HRV) as a Measure of the Effect of VNS Therapy on Vagal Tone

  Baseline, week 4, week 8

• Effect of VNS on Mucosal Inflammation

  Baseline (pre-VNS) and 4 weeks (post-VNS)

Study Arms (3)

Idiopathic Gastroparesis

EXPERIMENTAL

Patients with idiopathic gastroparesis and delayed gastric emptying. All patients in trial will be giving themselves vagal nerve stimulation for two minutes on each side twice a day in the morning and the night for four weeks starting at visit 3 and ending at visit 5.

Device: Vagal Nerve Stimulation

Diabetic Gastroparesis

EXPERIMENTAL

Patients with diabetic gastroparesis and delayed gastric emptying. All patients in trial will be giving themselves vagal nerve stimulation for two minutes on each side twice a day in the morning and the night for four weeks starting at visit 3 and ending at visit 5.

Device: Vagal Nerve Stimulation

Functional Dyspepsia

EXPERIMENTAL

Patients with functional dyspepsia and normal gastric emptying. All patients in trial will be giving themselves vagal nerve stimulation for two minutes on each side twice a day in the morning and the night for four weeks starting at visit 3 and ending at visit 5.

Device: Vagal Nerve Stimulation

Interventions

Vagal Nerve Stimulation DEVICE

Patients will be giving themselves vagal nerve stimulation for four weeks at interval of two times a day for two minutes on each side for four weeks. The impact of the intervention on gastroparesis symptoms will be measured by upper endoscopy biopsies, blood work, autonomic function tests, survey data, stool samples, urine sample, and saliva samples before after after the four weeks of stimulation treatment.

Diabetic Gastroparesis; Functional Dyspepsia; Idiopathic Gastroparesis

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female.
• Age 21-65 years old.
• Established diagnosis of functional dyspepsia, idiopathic or diabetic gastroparesis as per AGA (American Gastroenterology Association) guidelines.
• Patient is capable of giving informed consent and undergo upper endoscopy.
• Patient is on stable doses of other medications for gastroparesis for preceding 4 weeks prior to enrollment (baseline measures).

You may not qualify if:

• Surgical-related gastroparesis
• Extrinsic myopathy or neuropathy causing gastroparesis.
• Use of narcotic pain medications in the preceding 2 weeks of study enrollment.
• Patients with enteric feeding tubes or requiring parenteral nutrition (Patients with g-tubes who are stable for 3 months and not using the g-tube for venting may be eligible. patient with J-tubes are not eligible.
• Patients with severe flare requiring hospitalization.
• Untreated significant depression or suicidal thoughts.
• Pregnant or breast-feeding women.
• History of gastric pacemaker implantation.
• Patients with prior gastric surgery, including fundoplication, partial/total gastrectomy, or gastric bypass.
• Patients with malabsorption of enteric, pancreatic, or hepatibiliary etiology.
• Patients with primary pulmonary disorders that affect the spirulina breath test.
• Patients with implantable electronic devices.
• Patients with carotid artery atherosclerosis.

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University Medical Center

Redwood City, California, 94063, United States

Location

MeSH Terms

Conditions

Gastroparesis

Interventions

Vagus Nerve Stimulation

Condition Hierarchy (Ancestors)

Stomach Diseases; Gastrointestinal Diseases; Digestive System Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics

Limitations and Caveats

This trial had recruitment challenges due to the COVID19 pandemic with added cost of COVID testing prior to procedures. The idiopathic gastroparesis arm completed its planned enrollment but the other cohorts did not.

Results Point of Contact

• Title: Linda Nguyen
• Organization: Stanford University

nguyenlb@stanford.edu

650-736-0431

Study Officials

• Andres Gottfried, MD PHD

  Stanford University

  PRINCIPAL INVESTIGATOR

• Linda Nguyen, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor, Medicine - Gastroenterology & Hepatology

Model Details: 15 participants planned enrollment in each arm: * Diabetic Gastroparesis * Functional Dyspepsia * Idiopathic Gastoparesis

Study Record Dates

• First Submitted: April 11, 2017
• First Posted: April 19, 2017
• Study Start: March 1, 2017
• Primary Completion: August 24, 2018
• Study Completion: August 24, 2018
• Last Updated: September 13, 2023
• Results First Posted: April 5, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)